Articles Posted inMeningitis Outbreak

The furor over the mass outbreak of fungal meningitis continues. The U.S. Centers for Disease Control and Prevention issued updated information recently on the scope of the outbreak. According to their tallies, at least 480 patients have developed fungal meningits because of the contaminated epidural shots that they received. The death toll has also risen, with 33 individuals having died from meningitis complications. In most cases the deaths were caused by the patient suffering a stroke which was spurred by the fungal infection. We know that at least two of the infected patients are in Illinois. When the outbreak first made national news, officials from the Illinois Department of Public Health explained that three facilies (two in Chicago and one in Westerchester) were known to have distributed the steroids to patients. All told about 350 Illinois patients likely received the tainted shot.

Fury Over Lack of Oversight

In the months since the outbreak there has been growing concern regarding the apparent lack of oversight at the New England Compounding Center (NECC). Several members of Congress have begun asking tough questions of state and federal officials to better understand what went wrong and what should be done to prevent repeat occurrences.

The ramifications of the recalled spinal steroid situation continues to make waves across the eastern part of the country, including in Illinois. As we have repeatedly discussed, nearly 17,000 vials of a steroid used for back pain was contaminated with fungus at the New England Compounding Center (NECC). Some of those vials made their way to Illinois and were eventually given to patients at three different pain centers in and around Chicago. The contamination and injection exposed those patients to a very rare, but life-threatening form of brain and spinal cord inflammation known as fungal meningitis. It arises when a fungus enters the body and inflames certain membranes that protect the brain and spinal cord. It goes without saying that all those affected by this situation must act carefully.

According to the latest information provided on the CDC website on the matter, a second case of meningitis has been identified in Illinois, and counts in several other states have also gone up in recent weeks. Please take a look at this map to get an idea of the total scope of the current problem and the areas that have been hit the hardest. According to the latest data–which is consistently updated–there have been a total of 404 infections and 29 deaths. However, as has been noted, the incubation period for this fungal meningitis is particularly long. That means that it is premature to say that all those who received the contaminated injection are out of the woods. They are not. We encouarge all local residents to remain vigilant about their own health and those of loved ones who may have been exposed to this outrageous contamination.

Over the weekend various news outlets reported on the latest results from the U.S. Food and Drug Administation’s (FDA) investigation into the New England Compounding Center (NECC)–the “drug mixing” pharmaceutical plant at the center of the fungal meningitis outbreak that has swept large parts of the country. As we’ve shared frequently, several hundred medical patients–including some in Illinois–have developed funal meningitis as a result of contaminated spinal steroid injections given at local pain centers. Considering the seriousness of the outbreak, which has thus far taken the lives of at least two dozen people, state and federal regulators have intensely scrutinized the involved facility to determine the scope of the problem.

FDA Investigation into Meningitis Outbreak

According to an article on the situation from the Wall Street Journal, the FDA report offers a glimpse into obvious problems at the NECC. For one thing, the story notes that about one-fourth of the vials examined by federal regulators had very obvious greenish black material in the vials. At leat fifty vials were ultimately sent to the lab for closer investigations. Those results found that, shockingly, all fifty of those vials were contaminated with fungus. Over 17,000 vials of the spinal steroid were ultimately sent out to clinics in at least twenty three different states. At leat 14,000 of those vials may have been used before they were recalled in Septmber. And what these latest reports indicate is that those contaminated vials were not just flukes–the sterility problems at this facility were widespread.

When a major medical outbreak occurs, like the fungal meningitis incident which continues to sweep across the country, there is a tendency to overly focus on the numbers. How many contaminated spinal steroid vials were made? How many were used? How many people have been diagnosed so far? What is the current death count?

These figures provide a ready indicator of the overall scope of the problem and its trajectory. However, they do little to share the realities faced by individual families as a result of this unacceptable drug contamination. At the end of the day, however, that real-world reality is why we care about this in the first place–thousands are suffering. In our work as drug recall lawyers and on product liability cases, the attorneys at our firm have come to appreciate the value of understanding individual stories related to the tragedy. The numbers tell us one thing but the individual stories are ultimately more important. And from a legal persepctive, the civil justice system focuses on individual harm and the loss experienced by those affected.

So how exactly did this fungal meningitis outbreak happen? Was it an innocent mistake that could not have been prevented? Are the risk factors that caused this accident the same that affect other pharmaceutical compounding plants across the country? Is there anything that can be done to ensure no more families are forced to endure what thousands are enduring now in the wake of this deadly spinal steroid contamination?

These and similar questions are being asked by invovled parties across the country. We need to get to the bottom of this fiasco while ensuring all those affected are supported and those accountable are held to task.

It is far too early to make any definitive statements about this exact case. However, investigators, including many from the U.S. Food and Drug Administration as well as intrepid individual researchers, have uncovered details about the history and goings-on at the compounding plant. The information presented thus far is not pretty.

Seemingly every day brings news of more community members who have been infected with fungal meningitis, a rising number of whom are suffering serious injury (and even death) as a result. The meningitis outbreak is linked to a now-recalled spinal pain injection. A New England pharmaceutical compounding company is allegedly resonpsible for the situation.

According to estimates released by the U.S. Centers for Disease Control and Prevention (CDC), over 14,000 patients received the injections in pain centers across the country. The epidural shots were given mostly to help relieve back pain. However, unbeknownst to those receiveing the injections, the pain medication were tainted with a fungus. The fungus sometimes entered the body during the injection and may cause meningitis. Meningitis is an inflammation of protective membranes around the brain and spinal cord.

Earlier this week federal official released updated information on fungal meningitis infections which have affected hundreds across the country. Over the last two weeks we have discussed how this outbreak has spread across the country, with more and more involved patients identified. An NBC Newsreport on Wednesday provided even more sad news. According to the story another four medical patients have died as a result of the fungal meningitis they contracted via the infected spinal steroid injections. That brings the total of deaths to nineteen. RIght now the total infected count is at 247–a significant growth from when we first started discussing this story at the beginning of the month. The sickest patients to start–which likely included some seniors–seemed to face the most trouble as a result of the meningitis.

Amazingly, we still may not be near the end of the outbreak. Officials from the Center for Disease Control and Prevention report that the total number of infection is actually expected to rise even higher. That is because almost 17,000 vials of the steroid may have been sent out, with a majority of them actually used before they were recalled in late September.

The recent meningitis outbreak has led many to hear, for the first time, the term “compounding pharmacy.” This is the term used to describe the business which is allegedly at the heart of the latest outbreak. As blog readers know, the fungal meningitis problem was connected to a spinal steroid product at a New England compounding pharmacy.

Since the issue was discussed, investigators have further learned that the facility in question has a few other alleged problem in the past. A complaint was lodged against the company in 2002 which resulted in a 2006 consent decree authorizing detailed facility investigations by regulators. In addition, a 2004 lawsuit was filed by a woman who claims that her husband developed meningitis and died as a result of a contaminated spinal steroid injection–just as in this latest outbreak. That lawsuit was settled confidentially in 2005.

So what are these compounding pharmacies and what can they learn from this latest incident?

News about the pharmaceutical compounding firm at the center of the latest meningitis outbreak continues to pour in. As we reported, well over a hundred cases of meningitis have already been identified in various states across the country as a result of steroid injections that were tainted, allegedly by the pharmaceutical compounding company. Over 17,000 vials of the product were sent into the marketplace, according to various reports. Of that group, at least 13,000 may have been used in different clinics, including in Illinois. Those who received the drugs are at risk of developing a rare and dangerous fungal meningitis. Several cases have already resulted in deaths.

Past Problems

This week the Tennessean reported on new information related to past problems that the very same company had a few years ago involving meningitis contamination.

Besides facing basic day-to-day life challenges as a result of various age-related medical conditions, senior residents face increased long-term consequences from medical issues that affect people of all ages. There is a reason that seniors are the first ones urged to get flu shots then they become available–because contracting the flu can have more serious long-term consequences on seniors than other community members. Their bodies are often less able to fight back against the condition.

It is for that reason that local seniors and their family members should take notice of a new national health crisis that is making news across the country this week–a meningitis outbreak. According to a story on the issue from Reuters today, health officials are scrambling to get a handle of the situation which ultimately may affect thousands of people across the country.

Thus far, the U.S. Centers for Disease Control and Prevention notes that at least 105 cases have been identified in the last few days–every day seems to bring a few more cases. Sadly, at least eight people have died already as a result of the situation.

Search

Disclaimer

The purpose of this blog is to deliver news and information that is relevant to our areas of practice. The news and information reported on this blog represent the legal actions of attorneys throughout the United States. Our firm does not claim to represent plaintiffs in all of the lawsuits, settlements, and jury verdicts reported, only those noted as Levin & Perconti cases.